Transcript Market Surveillance in Republic of Turkey on Medical Devices Meral YILMAZ – Osman ARSLAN Ministry of Health Directorate General for Curative Services.

Market Surveillance in Republic of Turkey
on Medical Devices
Meral YILMAZ – Osman ARSLAN
Ministry of Health
Directorate General for Curative Services
• According to Article 8 of 1/95 numbered Association Council
Decision between EU and Turkey, establishing the Customs
Union between Turkey and EU, envisages that EU legislation
on abolishing technical obstacles to trade shall be included in
the internal legislation of Turkey.
•
According to 2/97 numbered Association Council Decision
between EU and Turkey the public institutions which will be
harmonising the EU legislation are determined by the Cabinet
Decision 15.1.1997 dated and 97/9196 numbered.
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• Council of Ministers assigned Ministry of
Health for the harmonisation of the legislation
on medical devices.
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• Necessary regulation for the effectively implementation of the
technical legislation has been provided by 4703 numbered Act
on “Preparation and Implementation of the Technical
Legislation for the Products”. This act is the legal framework
and it came into force on January 11th, 2002.
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Based on this legal framework following Directives on
medical devices have been harmonised by the Ministry of
Health.
• 93/42/EEC Medical Devices Directive
• 90/385/EEC Active Implantable Medical DevicesDirective
(These two regulations are in force since 31.12.2003.)
• 98/79/EC In-vitro Diagnostic Medical Devices Directive
(This regulation is in force since 14.04.2004.)
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Amendments of these regulations have been republished in the
official gazette on 09.01.2007. Following amendments have
been realised:
• Directive of 2000/70/EC on Medical Devices Incorporating
Stable Derivates of Human Blood or Human Plasma,
• Directive of 2001/104/EC amending the Medical Devices
Directive
• Council Directive of 2003/12/EC on Reclassification of the
Breast Implants which amended Directive of 93/42/EEC on
Medical Devices
have been included in the Regulation on Medical Devices.
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Market Surveillance activities for the medical devices
are carried out by the Ministry of Health, Directorate
General for Curative Services, Department of
Biomedical Engineering Services.
In addition to the Regulation on Medical Devices,
following legislation is taken into consideration for
market surveillance purposes in our country:
- 4703 numbered act
- Regulation on the procedure of market surveillance
activities carried out by Ministry of Health
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Market Surveillance of Medical Devices:
performed by following means:
• Notifications received from the natural and
legal person,
• Notifications received from public bodies,
• Notifications received from public (media,
print media etc.),
• Notifications received from other countries
vigilance systems,
• Risk evaluation etc.
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Case
Number
Rate
Not in compliance
with the legislation
39
45,9 %
In compliance with
the legislation
32
37.7 %
Other
14
16.4 %
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Action
Corrective actions
have been taken
Giving up the
business by the firm,
wrong notification,
cases which are
under the
responsibility of other
institutions etc.
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Thank you for your kind attention.
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